Using targeted delivery, a controlled dose of a therapeutic agent may be delivered directly to a target site, e.g., a lesion in a diseased vessel, while avoiding or minimizing exposing other parts of the body to the agent. Also, greater amounts of therapeutic agent may be delivered to the afflicted parts of the body. In one approach to localized delivery, a balloon catheter is used, wherein the balloon has therapeutic agent disposed on its outer surface and is expanded within a vessel to deliver the therapeutic agent to the vessel wall. In an alternative approach, an expandable sheath is disposed around a balloon and a coating disposed on the expandable sheath, the coating including a therapeutic agent. There is still a need for improved balloon catheter devices for delivery of one or more therapeutic agents to an intravascular site.